Audio-visual Stimulation for Sleep Promotion in Older Adults With Osteoarthritis Pain
Primary Purpose
Insomnia Chronic, Osteoarthritis, Pain, Chronic
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Audiovisual Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia Chronic
Eligibility Criteria
Inclusion Criteria:
- 60 years or older
- Having difficulty sleeping over the past three months (Insomnia Severity Index ≥ 8)
- Having osteoarthritis pain (Brief Pain Inventory Worst pain ≥ 4)
Exclusion Criteria:
- Working night shift
- Previously diagnosed with a primary sleep disorder (Sleep Apnea or Restless Leg Syndrome).
- Seizure disorder
- Photosensitivity
- Dementia
- Diagnosis or other significant chronic illness beyond OA that would impact sleep
- Severe psychiatric disorder including a history of or current diagnosis of psychosis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active AVS
Placebo Control AVS
Arm Description
Active AVS consists of a 30-minute pulsing lights (red, green, blue) and sounds that gradually descend from alpha (10 Hz) to delta (2 Hz).
The placebo control AVS program consists of 30 minutes of constant dim light that slowly changes in color, and a steady monotone at ultra-low (<1 Hz) frequency (outside of the entrainment range).
Outcomes
Primary Outcome Measures
Insomnia of Severity Index
A 7-item questionnaire that is a global measure of perceived insomnia severity. Items use a 5-point scale for total scores of 0-28, with >15 considered moderate severity. The ISI has good internal consistency and is sensitive to changes in sleep of older adults in clinical and research.
Pittsburgh Sleep Quality Index (PSQI)
Self-rating of overall sleep quality and disturbances using 7 sleep components. A PSQI global score >5 is highly sensitive and specific for distinguishing good and poor sleepers.
Brief Pain Inventory (BPI) short form
The BPI is a 9-item questionnaire that assesses severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week.
Secondary Outcome Measures
Patient Health Questionnaire
The PHQ-9 is a 9-item reliable, valid, measure that rates depression symptom severity on a 4-point scale.
Sleep Diary
The sleep diary is a two-page sleep log with standard fill in the blank questions about the quantity and quality of the previous night of sleep, including Time to Bed, Sleep Latency, Number of Awakenings, Wake After Sleep Onset time, Total Sleep Time, and Time out of Bed. The diary also includes questions about the causes of sleep difficulties and ratings of daytime fatigue and sleepiness.
Actigraphy
Sleep and wake pattern (actigraph) will be measured by Philips Respironics Actiwatch-2. Actigraphy is a reliable and objective tool to monitor sleep-wake cycles in ambulatory individuals (including older adults) based on frequency and magnitude of movements.
Quantitative Electroencephalogram (QEEG)
Cortical activity will be evaluated using a 19-channel quantitative electroencephalographic system (Discovery 24E, BrainMaster)30 with a standard electrode cap that has 22 sensors attaching to the scalp.
Full Information
NCT ID
NCT03441191
First Posted
February 15, 2018
Last Updated
February 20, 2018
Sponsor
University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT03441191
Brief Title
Audio-visual Stimulation for Sleep Promotion in Older Adults With Osteoarthritis Pain
Official Title
Audio-visual Stimulation for Sleep Promotion in Older Adults With Osteoarthritis Pain
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2014 (Actual)
Primary Completion Date
November 1, 2016 (Actual)
Study Completion Date
November 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background and Purpose: The purpose of the study is to test the efficacy of an audio-visual stimulation program for sleep promotion in adults with chronic pain. The hypothesis is that hyper-arousal plays an important role in insomnia. Brainwave entrainment from 8 to 1 Hz reduces arousal, and thereby improves sleep. Improved sleep may change how people perceive pain.
Methods: Using a double-blind, randomized controlled trial design, we plan to enroll 30 adults (21-65 years old) experiencing both nonmalignant pain and insomnia. Exclusion criteria include: seizure disorder, sleep disorder, and night shift workers. After a one-week baseline measure, participants will be randomized to intervention or placebo group. Participants in both groups will be asked to self-administer the audio-visual stimulation program every night at bedtime for one month. Upon completion, post intervention measures will be collected.
Detailed Description
Background: The purpose of this pilot study was to test the efficacy of an open-looped Audio-visual Stimulation program (AVS) for sleep promotion in older adults with osteoarthritis pain. In this study, the AVS program was tested in a randomized controlled design. Specifically, this pilot study examined a 30-minute audio-visual stimulation program that gradually ramped from 10 Hz down to 2 Hz, to be used at bedtime for delta brainwave induction, in a randomized controlled design. The placebo control AVS program consisted of 30-minutes of constant dim light that slowly changed in color, and a steady monotone at ultra-low (<1 Hz) frequency (outside of the entrainment range).
Method: A total of 30 older adults (mean age 68 ± 5.1, 90% women) with comorbid insomnia and osteoarthritis pain participated in this 2-week study. Participants were randomly assigned to either AVS active program or AVS placebo control program. After the baseline assessment (which included questionnaires [sleep, pain, depression], and quantitative electroencephalogram (QEEG) during AVS induction), participants were asked to self-administer their group specific AVS program nightly at bedtime for two weeks. Post-treatment questionnaires (sleep, pain, depression) were then collected.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia Chronic, Osteoarthritis, Pain, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active AVS
Arm Type
Experimental
Arm Description
Active AVS consists of a 30-minute pulsing lights (red, green, blue) and sounds that gradually descend from alpha (10 Hz) to delta (2 Hz).
Arm Title
Placebo Control AVS
Arm Type
Placebo Comparator
Arm Description
The placebo control AVS program consists of 30 minutes of constant dim light that slowly changes in color, and a steady monotone at ultra-low (<1 Hz) frequency (outside of the entrainment range).
Intervention Type
Device
Intervention Name(s)
Audiovisual Stimulation
Intervention Description
A commercially available AVS device (MindPlace Procyon) modified for use in the current study will be used to deliver the AVS programs in this study
Primary Outcome Measure Information:
Title
Insomnia of Severity Index
Description
A 7-item questionnaire that is a global measure of perceived insomnia severity. Items use a 5-point scale for total scores of 0-28, with >15 considered moderate severity. The ISI has good internal consistency and is sensitive to changes in sleep of older adults in clinical and research.
Time Frame
2 weeks post baseline
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Self-rating of overall sleep quality and disturbances using 7 sleep components. A PSQI global score >5 is highly sensitive and specific for distinguishing good and poor sleepers.
Time Frame
2 weeks post baseline
Title
Brief Pain Inventory (BPI) short form
Description
The BPI is a 9-item questionnaire that assesses severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week.
Time Frame
2 weeks post baseline
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire
Description
The PHQ-9 is a 9-item reliable, valid, measure that rates depression symptom severity on a 4-point scale.
Time Frame
2 weeks post baseline
Title
Sleep Diary
Description
The sleep diary is a two-page sleep log with standard fill in the blank questions about the quantity and quality of the previous night of sleep, including Time to Bed, Sleep Latency, Number of Awakenings, Wake After Sleep Onset time, Total Sleep Time, and Time out of Bed. The diary also includes questions about the causes of sleep difficulties and ratings of daytime fatigue and sleepiness.
Time Frame
baseline through 2 weeks post baseline
Title
Actigraphy
Description
Sleep and wake pattern (actigraph) will be measured by Philips Respironics Actiwatch-2. Actigraphy is a reliable and objective tool to monitor sleep-wake cycles in ambulatory individuals (including older adults) based on frequency and magnitude of movements.
Time Frame
baseline through 2 weeks post baseline
Title
Quantitative Electroencephalogram (QEEG)
Description
Cortical activity will be evaluated using a 19-channel quantitative electroencephalographic system (Discovery 24E, BrainMaster)30 with a standard electrode cap that has 22 sensors attaching to the scalp.
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
60 years or older
Having difficulty sleeping over the past three months (Insomnia Severity Index ≥ 8)
Having osteoarthritis pain (Brief Pain Inventory Worst pain ≥ 4)
Exclusion Criteria:
Working night shift
Previously diagnosed with a primary sleep disorder (Sleep Apnea or Restless Leg Syndrome).
Seizure disorder
Photosensitivity
Dementia
Diagnosis or other significant chronic illness beyond OA that would impact sleep
Severe psychiatric disorder including a history of or current diagnosis of psychosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Tang, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
25931250
Citation
Tang HY, Vitiello MV, Perlis M, Riegel B. Open-Loop Neurofeedback Audiovisual Stimulation: A Pilot Study of Its Potential for Sleep Induction in Older Adults. Appl Psychophysiol Biofeedback. 2015 Sep;40(3):183-8. doi: 10.1007/s10484-015-9285-x.
Results Reference
background
PubMed Identifier
25257144
Citation
Tang HY, Vitiello MV, Perlis M, Mao JJ, Riegel B. A pilot study of audio-visual stimulation as a self-care treatment for insomnia in adults with insomnia and chronic pain. Appl Psychophysiol Biofeedback. 2014 Dec;39(3-4):219-25. doi: 10.1007/s10484-014-9263-8.
Results Reference
background
PubMed Identifier
26294268
Citation
Tang HY, Riegel B, McCurry SM, Vitiello MV. Open-Loop Audio-Visual Stimulation (AVS): A Useful Tool for Management of Insomnia? Appl Psychophysiol Biofeedback. 2016 Mar;41(1):39-46. doi: 10.1007/s10484-015-9308-7.
Results Reference
background
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Audio-visual Stimulation for Sleep Promotion in Older Adults With Osteoarthritis Pain
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